Division 7.4 Section IV: studies concerning the efficacy of the additive

The requirements for the different categories/functional group of additives apply.

When the additive, for which animal studies are required, has been previously authorised for other physiological similar species, no further demonstration of efficacy is required provided the requested effect and mode of action are the same. If the additive has not been previously authorised, the requested effect, or the mode of action are different than former authorisation, efficacy shall be demonstrated following the general rules for Section IV in Annex II.

The duration of the long term efficacy trials shall be at least 28 days.